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Clinical Trials/CTRI/2019/02/017770
CTRI/2019/02/017770
Completed
Phase 4

A Prospective, Multicenter, Open Label, Phase IV Clinical Trial to Test Efficacy and Safety of Highly Purified Human Chorionic Gonadotropin For Inducing Final Follicular Maturation in Assisted Reproductive Technique(ART) - HuCoG-HP

Bharat Serums and Vaccines Ltd0 sites200 target enrollmentTBD
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Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Bharat Serums and Vaccines Ltd
Enrollment
200
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Pms

Investigators

Sponsor
Bharat Serums and Vaccines Ltd

Eligibility Criteria

Inclusion Criteria

  • •1\. Subject undergoing ovulation induction with injectable gonadotropins with least 1 follicle \>\= 18 mm in size.
  • •2\. Subject aged \>20 or \<40 (Both inclusive)
  • •3\. BMI between 18 and 30 kg/m2\.
  • •4\. Normogonadotrophic subjects with normal hormonal profile.
  • •5\. Male partner with semen parameters compatible with ART using ejaculated sperm.
  • •6\. Normal Uterine cavity and at least one normal tube confirmed on 3D US and Hystero Contrast Salpingogram (HycoSy) or hystosalpingogram (HSG) \&/or Laparoscopy within 3 years before recruitment.
  • •7\. Transvaginal ultrasound documenting the presence of both ovaries, without evidence of abnormality (e.g. no endometrioma)and normal adnexa (e.g. no hydrosalphinx) within 6 months before recruitment.
  • •8\. Signed informed consent form before screening

Exclusion Criteria

  • •1\. Subject 20 or 40 years of age.
  • •2\. Infertility attributable to severe endometriosis (grade III or IV).
  • •3\. Subjects whose male partner needs surgical sperm retrieval.
  • •4\. Pelvic pathology that would compromise ART success.
  • •5\. Any chronic systemic disease including uncorrected hyperthyroid, hypothyroid hyperprolactinemia
  • •6\. Pregnancy, lactation or contraindication to pregnancy
  • •7\. Current or past ( last 12 months) abuse of alcohol and drugs.
  • •8\. Undiagnosed vaginal bleeding .
  • •9\. Tumors of the ovary, breast, adrenal gland, pituitary or hypothalamus and malformation of sexual organs incompatible with pregnacy.
  • •10\. Hypersensitivity to any trial product.

Outcomes

Primary Outcomes

Not specified

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